Narrow-band Imaging, Autofluorescence Imaging and Gastroesophageal Reflux Disease

Gastroesophageal Reflux Disease Clinical Trial

Official title:

Diagnostic Value of Narrow-band Imaging, Autofluorescence Imaging & White-light Imaging on Gastroesophageal Reflux Disease

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01504971
• Other study ID #: 20111013-001
• Status: Active, not recruiting
• Phase: N/A
• First received: January 4, 2012
• Last updated: August 4, 2015
• Start date: January 2011
• Est. completion date: December 2016

Study information

• Verified date: August 2015
• Source: Chinese PLA General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Observational

Clinical Trial Summary

Aim of this study is to compare the efficacy of narrow band imaging (NBI) and autofluorescence imaging (AFI) to distinguish subtle mucosal change related to acid reflux that is not visible in standard white light imaging (WLI) endoscopy, and help indicating the diagnosis of gastroesophageal reflux disease (GERD).

Description:

GERD is a common condition that develops when the reflux of gastric and/or duodenal contents causes troublesome symptoms with or without mucosal damage or complications. Despite the high prevalence of GERD in the general population, up to 60% of patients with reflux symptoms is insufficiently characterized as having normal endoscopic finding based on standard WLI endoscopy: non-erosive reflux diseases (NERD).

NBI is an optical-digital imaging technology that uses two specific narrow-banded shot wavelength lights (400-430 nm and 525-555 nm) instead of broad band white light. The NBI contrasts surface structure and vascular architecture of the superficial mucosa and facilitates evaluation of indistinct mucosal morphology. AFI produces real-time computed images of endoscopically detected autofluorescence emitted from endogenous fluorophores in the digestive tract (collagen, nicotinamide, adenine dinucleotide, flavin, and porphyrins) caused by light excitation. The AFI can identify lesions due to differences in tissue fluorescence properties that are not detectable by standard WLI. Hence, our hypothesis is that new endoscopic imaging i.e. NBI and AFI would help to identify subtle mucosal change which indicates the diagnosis of GERD

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 95
• Est. completion date: December 2016
• Est. primary completion date: June 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

1. Inclusion criteria

• GERD symptom: heartburn or regurgitation (either one) at least 2 days a week

• Presence of symptom for longer than 1 month before screening

• Provision of written informed consent

2. Exclusion criteria:

• Any known esophageal disease or disorder, other than reflux esophagitis

• Active or healing gastroduodenal ulcer (except scars)

• History of esophageal or gastric surgery.

• Clinically significant heart, lung, liver or kidney disease

• Allergy to proton-pump inhibitor

• Pregnancy

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Gastroesophageal Reflux
• Gastroesophageal Reflux Disease

Intervention

Other:
• symptom questionaire
GerdQ questionaire

Procedure:
• pH monitoring
24-hour pH monitoring
• Tri-modal imaging endoscopy
To investigate WLI,NBI and AFI

Drug:
• rabeprazole
10mg, bid, p.o.

Locations

Country	Name	City	State
China	Outpatient Department Building	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chinese PLA General Hospital

Country where clinical trial is conducted

China, 

References & Publications (1)

Fock KM, Teo EK, Ang TL, Tan JY, Law NM. The utility of narrow band imaging in improving the endoscopic diagnosis of gastroesophageal reflux disease. Clin Gastroenterol Hepatol. 2009 Jan;7(1):54-9. doi: 10.1016/j.cgh.2008.08.030. Epub 2008 Sep 3. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic Ability of Each Endoscopic Finding for GERD Symptom.	Patients with GERD symptom receive endoscopic tri-modal imaging within 1 month	1 month	Yes
Secondary	Association of Each Endoscopic Finding With Symptom Score	Symptom score is assessed by a self-reported questionnaire	1 month	No
Secondary	Association of Each Endoscopic Finding With pH Monitoring Result		1 month	Yes
Secondary	Association of Each Endoscopic Finding With Treatment Effect of PPI	Treatment effect of PPI is assessed by changes of symptom score	2 month	No